Understanding randomised controlled trials
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The hierarchy of evidence in assessing the effectiveness of interventions or treatments is explained, and the gold standard for evaluating the effectiveness of interventions, the randomised controlled trial, is discussed. Issues that need to be considered during the critical appraisal of randomised controlled trials, such as assessing the validity of trial methodology and the magnitude and precision of the treatment effect, and deciding on the applicability of research results, are discussed. Important terminologies such as randomisation, allocation concealment, blinding, intention to treat, p values, and confidence intervals are explained.
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RCTs are the gold standard for evaluating the efficacy of an intervention.
“randomised controlled trials (RCTs), which are well known to be the gold standard for evaluating the efficacy of an intervention.11”
From Efficacy and safety of osteopathic manipulative treatment: an overview of systematic reviews (2022) · cites this paper as [11]
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Assessing the quality of reports of randomized clinical trials: Is blinding necessary?
Jadad, A. R., Moore, R. A., Carroll, D., Jenkinson, C., Reynolds, D. J. M., Gavaghan, D. J., & McQuay, H. J. (1996) · Controlled Clinical Trials · doi:10.1016/0197-2456(95)00134-4 · Cited by 17,582 · see citing works
Meta-analysis: Principles and procedures
Egger, M., Smith, G. D., & Phillips, A. N. (1997) · BMJ · doi:10.1136/bmj.315.7121.1533 · Cited by 2,415 · see citing works
Deeks, J. J., Altman, D. G., & Bradburn, M. J. (2001) · Systematic Reviews in Health Care · doi:10.1002/9780470693926.ch15 · Cited by 2,163 · see citing works
Hierarchy of evidence: a framework for ranking evidence evaluating healthcare interventions
Evans, D. (2003) · Journal of Clinical Nursing · doi:10.1046/j.1365-2702.2003.00662.x · Cited by 993 · see citing works
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- Steves R, Hootman JM. Evidence-based medicine: what is it and how does it apply to athletic training? J Athl Train 2004;39:83-7.
- Brownson RC, Baker EA, Leet TL, et al. Evidence based public Health. New York: Oxford University Press, 2003.
- Gray GE, Pinson LA. Evidence-based medicine and psychiatric practice. Psychiatr Q 2003;74:387-99.
- Sackett DL. Evidence-based medicine. Semin Perinatol 1997;21:3-5.
- Levi M. Formulating clinical questions. In: McGovern DPB, Valori RM, Summerskill WSM, Levi M, eds. Key topics in evidence based medicine. Oxford; BIOS Scientific Publishers, 2001.
- Carneiro AV. The correct formulation of clinical questions for the practice of evidence based medicine. Acta Med Port 1998;11:745-8.
- Rosenberg WM, Sackett DL. On the need for evidence-based medicine. Therapie 1996;51:212-7.
- Jordaan M, Jones R. Adoption of internet technology by UK postgraduate centres: a questionnaire survey. Health Libr Rev 1999;16:166-73.
- Rosenberg WM, Deeks J, Lusher A, et al. Improving searching skills and evidence retrieval. J R Coll Physicians Lond 1998;32:557-63.
- Rosenberg W, Donald A. Evidence based medicine: an approach to clinical problem-solving. BMJ 1995;310:1122-6.
- Straus SE, Sackett DL. Using research findings in clinical practice. BMJ 1998;317:339-42. REFERENCES
- Akobeng AK. Evidence-based child health. 1. Principles of evidence-based medicine. Arch Dis Child 2005;90:837-40.
- Rychetnik L, Hawe P, Waters E, et al. A glossary for evidence based public health. J Epidemiol Community Health 2004;58:538-45.
- Last JM. A dictionary of epidemiology. New York: Oxford University Press, 2001.
- McGovern DPB. Randomized controlled trials. In: McGovern DPB, Valori RM, Summerskill WSM, eds. Key topics in evidence based medicine. Oxford: BIOS Scientific Publishers, 2001:26-9.
- Roberts C, Torgesson D. Randomisation methods in controlled trials. BMJ 1998;317:1301-10.
- Altman DG, Bland JM. How to randomise. BMJ 1999;319:703-4.
- Chia KS. Randomisation: magical cure for bias. Ann Acad Med Singapore 2000;29:563-4.
- Schulz KF, Chalmers I, Hayes RJ, et al. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995;273:408-12.
- Torgerson DJ, Roberts C. Randomisation methods: concealment. BMJ 1999;319:375-6.
- Torgerson DJ, Torgerson CJ. Avoiding bias in randomised controlled trials in educational research. Br J Educ Stud 2003;51:36-45.
- Day SJ, Altman DG. Blinding in clinical trials and other studies. BMJ 2000;321:504.
- Schulz KF. Assessing allocation concealment and blinding in randomised controlled trials: why bother? Evid Based Nurs 2000;5:36-7.
- Summerskill WSM. Intention to treat. In: McGovern DPB, Valori RM, Summerskill WSM, eds. Key topics in evidence based medicine. Oxford: BIOS Scientific Publishers, 2001:105-7.
- Altman DG, Schulz KF, Moher D, et al. The revised CONSORT statement for reporting randomised controlled trials: explanation and elaboration. Ann Intern Med 2001;134:663-94.
- Devane D, Begley CM, Clarke M. How many do I need? Basic principles of sample size estimation. J Adv Nurs 2004;47:297-302.
- Akobeng AK. Understanding measures of treatment effect in clinical trials. Arch Dis Child, 2005;90, 54-6.
- Akobeng AK. Evidence based child health 1. Principles of evidence based medicine. Arch Dis Child 2005;90:837-40.
- Cook DJ, Mulrow CD, Haynes RB. Systematic reviews: synthesis of best evidence for clinical decisions. Ann Intern Med 1997;126:376-80.
- Pai M, McCulloch M, Gorman JD, et al. Systematic reviews and meta- analyses: an illustrated, step-by-step guide. Natl Med J India 2004;17:86-95.
- McGovern DPB. Systematic reviews. In: McGovern DPB, Valori RM, Summerskill WSM, eds. Key topics in evidence based medicine. Oxford: BIOS Scientific Publishers, 2001:17-9.
- McAlister FA, Clark HD, van Walraven C, et al. The medical review article revisited: has the science improved? Ann Intern Med 1999;131:947-51.
- Mulrow CD. Systematic reviews: rationale for systematic reviews. BMJ 1994;309:597-9.
- Akobeng AK. Evidence based child health 2. Understanding randomised controlled trials. Arch Dis Child 2005;90:840-4.
- Greenhalgh T. How to read a paper: papers that summarise other papers (systematic reviews and meta-analyses). BMJ 1997;315:672-5.
- Lewis S, Clarke M. Forest plots: trying to see the wood and the trees. BMJ 2001;322:1479-80.
- D'Souza AL, Rajkumar C, Cooke J, et al. Probiotics in prevention of antibiotic associated diarrhoea: meta-analysis. BMJ 2002;324:1361.
- Dickersin K, Scherer R, Lefebvre C. Systematic reviews: identifying relevant studies for systematic reviews. BMJ 1994;309:1286-91.
- Clarke M, Oxman AD, eds. Selecting studies. Cochrane reviewers' handbook 4.2.0 [updated March 2003]. In: The Cochrane library, issue 2. Oxford: Update Software, 2003. REFERENCES
- Akobeng AK. Evidence based child health. 1. Principles of evidence based medicine. Arch Dis Child 2005;90:837-40.
- Targan SR, Hanauer SB, van Deventer SJH, et al. A short term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn's disease. N Engl J Med 1997;337:1029-35.
- Baldassano R, Braegger CP, Escher JC, et al. Infliximab (REMICADE) therapy in the treatment of pediatric Crohn's disease. Am J Gastroenterol 2003;98:833-8.
- D'haens G, van Deventer S, van Hogezand R, et al. Endoscopic and histological healing with infliximab anti-tumor necrosis factor antibodies in Crohn's disease: a European multicenter trial. Gastroenterology 1999;116:1029-34.
- Clarke M, Oxman AD, eds. Cochrane Reviewers' Handbook 4.1.4 (updated October 2001). In: The Cochrane Library, Issue 4, 2001. Oxford: Update software.
- Akobeng AK. Understanding measures of treatment effect in clinical trials. Arch Dis Child 2005;90:54-6.
- Linzer M, Brown JT, Frazier LM, et al. Impact of a medical journal club on house-staff reading habits, knowledge, and critical appraisal skills. A randomised controlled trial. JAMA 1988;260:2537-41.
- Kellum JA, Rieker JP, Power M, et al. Teaching critical appraisal during critical care fellowship training: a foundation for evidence-based critical care medicine. Crit Care Med 2000;28:3067-70.
- Neville AJ, Reiter HI, Eva KW, et al. Critical appraisal turkey shoot: linking critical appraisal to clinical decision making. Acad Med 2000;75:S87-9.
- Green ML. Evidence-based medicine training in graduate medical education: past, present and future. J Eval Clin Pract 2000;6:121-38.
- Elnicki DM, Halperin AK, Shockcor WT, et al. Multidisciplinary evidence- based medicine journal clubs: curriculum design and participants' reactions. Am J Med Sci 1999;317:243-6.
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- Authors
- Akobeng, A. K.
- Corresponding author
- Akobeng, A K
- ORCID
- Akobeng, A K
- Venue
- Archives of Disease in Childhood
- Publisher
- BMJ
- Published
- 2005-08-01
- Volume
- 90
- Issue
- 8
- Pages
- 840-844
- ISSN
- 0003-9888 (ISSN-L)
- 1468-2044
- PMC
- PMC1720509
- OpenAlex
- W2139339819
- Cited by
- 458
- References
- 4
- Citations by year
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- FWCI
- 8.47
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Archives of Disease in Childhood (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- HighWire Press Open Archive (submittedVersion)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
- Keywords
- randomized controlled trials, evidence hierarchy, critical appraisal, trial validity, treatment effect estimation, randomization, allocation concealment, blinding, intention-to-treat analysis, p-values, confidence intervals
- MeSH terms
- Child, Child Welfare, Decision Making, Humans, Pediatrics, Reproducibility of Results, Randomized Controlled Trials as Topic, Evidence-Based Medicine, Comprehension
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